Laryngeal Mask Supreme™ Versus the I-gel™

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT00653237

First received: April 1, 2008

Last updated: March 11, 2014

Last verified: March 2014

History of Changes

Purpose

We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

Condition	Intervention
Patients Undergoing Elective General Anesthesia	Device: I-gel and LMA Supreme: supraglottic airway devices


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

first attempt success rate and time to success [ Time Frame: during intervention ]

Secondary Outcome Measures:

leak pressure [ Time Frame: during intervention ]


Enrollment:	60
Study Start Date:	March 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 crossover trial. insertion of both devices consecutively, computer randomized order	Device: I-gel and LMA Supreme: supraglottic airway devices Insertion of a supraglottic airway device Other Name: Laryngeal Mask Supreme, supraglottic airway device

Detailed Description:

The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

ASA 1-3 patients undergoing elective operation

Exclusion Criteria:

Not speaking german or refusing to participate
BMI >35, <50kg
Planned operation time >4h
High risk of aspiration
Cervical spine disease, known difficult airway, mouth opening <20mm
Upper respiratory tract symptoms in the previous 10 days
Preoperative sore throat
Poor dentition with high risk of damage

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653237

Locations


Switzerland
University Hospital
Berne, Switzerland, CH-3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators


Study Director:	Robert Greif, M.D.	Department of Anesthesia, University Hospital Berne, Switzerland

More Information


Responsible Party:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00653237 History of Changes
Other Study ID Numbers:	igellma-1
Study First Received:	April 1, 2008
Last Updated:	March 11, 2014

Additional relevant MeSH terms:


Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Disinfectants

ClinicalTrials.gov processed this record on June 28, 2017

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